NS AND USAGE
1.1 Subcutaneous Fluid Administration
1.2 Dispersion and Absorption of Injected Drugs
1.3 Subcutaneous Urography
2 DOSAGE AND ADMINISTRATION
2.1 Subcutaneous Fluid Administration (Hypodermoclysis)
2.2 Absorption and Dispersion of Injected Drugs
2.3 Subcutaneous Urography
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Spread of Localized Infection
5.2 Ocular Damage
5.3 Enzyme Inactivation with Intravenous Administration
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Incompatibilities
7.2 Drug Specific Precautions
7.3 Local Anesthetic Agent
7.4 Salicylates, Cortisone, ACTH, Estrogens, Antihistamines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Important Precautions Regarding VITRASE
17.2 What Patients Should Know About Adverse Reactions
17.3 Patients Should Inform Their Doctors If Taking Other Medications
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Sections or subsections omitted from the full prescribing information are not listed.
•1 INDICATIONS AND USAGE
1.1 Subcutaneous Fluid Administration
VITRASE (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
1.2 Dispersion and Absorption of Injected Drugs
VITRASE is indicated as an adjuvant to increase dispersion and absorption of other injected drugs.
1.3 Subcutaneous Urography
VITRASE is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents.
•2 DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
VITRASE (hyaluronidase injection) should be administered as discussed below, since its effects relative to absorption and dispersion of other drugs are not produced when it is administered intravenously.
Draw the desired amount of VITRASE into the syringe to obtain the target Hyaluronidase Activity (USP Units) according to the table below.
Amount of VITRASE Solution Withdrawn Per Target Hyaluronidase Activity
Target Hyaluronidase Activity (USP Units) Volume Withdraw from Vial (mL)
50 Units 0.25 mL
75 Units 0.38 mL
150 Units 0.75 mL
200 Units 1.0 mL
After admixture with drug, store at 15-25°C (59-77°F) and use within 6 hours.
2.1 Subcutaneous Fluid Administration (Hypodermoclysis)
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject VITRASE (hyaluronidase injection) into rubber tubing close to needle.
An alternate method is to inject VITRASE under skin prior to clysis. 200 Units will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer’s etc |
